Talk With Me Baby Program to Improve Early Home Language for Infants
Delivered During Well-Child Visits for Children Up to 9 Months Old
Led by IDeA States Pediatric Clinical Trials Network · Updated on 2025-08-29
66
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating whether the Talk With Me Baby TWMB program can improve the home-language environment for families with infants aged two to six months, especially those at risk. The study focuses on whether this program, delivered during routine well-child visits, can increase the time caregivers spend talking to their infants. It aims to understand how enhancing caregiver-infant communication during early development impacts language and behavior in infants.
The study involves embedding the TWMB program into standard well-child care visits. Participants will attend up to four consecutive well-child checkups within a 12-month period, during which primary care providers will deliver the TWMB language-promotion intervention alongside usual care. Caregivers will receive this program at each visit to support language development in their infants.
During the study, caregivers will record their conversations with their infants before and after receiving the TWMB intervention across four sessions. Researchers will assess changes in language promotion behaviors using the Language Environment Analysis LENA system, focusing on conversational turn counts and adult word counts over a 12-month period. The involvement includes attending well-child visits, participating in the intervention, and completing language recordings to monitor progress and outcomes.
CONDITIONS
Brief Title
Talk With Me Baby to Enhance the Early Home Language Environment
Research Team
S
Song Ounpraseuth, PhD
D
DeAnn E Hubberd, MA
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Talk With Me Baby (TWMB) intervention
Clinic‑based literacy promotion (e.g., Reach Out and Read)
What it is
A single‑group behavioral language‑promotion intervention delivered by caregivers during up to four routine Well‑Child Care visits over 12 months
A common primary‑care approach using literacy promotion (for example Reach Out and Read) delivered in well‑child visits to encourage caregiver‑child shared reading
Role in the study
Investigational intervention evaluated by applying it during routine visits
Not evaluated in this trial; serves as external context
Primary purpose
To promote caregiver‑child language interaction behaviors at home through embedded support in clinic visits
To encourage shared reading and early literacy habits that support language development
How it is delivered
Delivered by primary‑care staff to caregivers during routine Well‑Child Care visits up to four times
Delivered by primary‑care providers during well‑child visits, commonly using book distribution and reading guidance
Evidence status
Effectiveness is currently under study; outcomes will assess changes in caregiver language‑promotion behaviors
Supported by evidence showing increased shared reading and early language from clinic‑based literacy programmes
Important limitations
No control group and limited to eligible dyads; effectiveness beyond routine visits is untested
May not reach children with minimal caregiver literacy or in non‑book‑reading cultures; depends on caregiver engagement
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 0Months - 9Months
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Caregiver who will receive the Talk With Me Baby program during routine well-child care visits at participating clinics
Child receiving well-child care at a participating clinic
Caregiver is an adult as defined by their state of residency
Caregiver can complete study measures in English
Caregiver has legal authority to consent for themselves and their child
Caregiver-child dyad has a Language Environment Analysis baseline score at or below the 75th percentile
Child is zero to nine months old (+ 0-30 days) at enrollment
Child was born at full term (more than 37 weeks gestation)
Child was born as a singleton (only one baby delivered)
You will not qualify if you...
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 12 months
Participants receive the Talk With Me Baby language-promotion intervention embedded within up to 4 consecutive routine Well-Child Care visits over a 12-month period.
Up to 4 routine Well-Child Care visits
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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Published Research Related To This Trial
Study protocol for a pilot evaluation of Talk With Me Baby (TWMB) for Well-Child Care: A primary care-integrated language promotion intervention in rural and underserved clinics.